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ICT: Maximising Strategic Development for Digital Medicines and Therapeutics

May 26, 2022

Robb Lawrence, Senior Vice President, Commercial Strategy
Shauna Swanson, Manager, Regulatory Affairs

The market for digital health products is large and rapidly expanding. At the end of 2020, there were over 350,000 unique digital health applications being marketed to users. In 2021, over $37.9 billion in new capital was invested in digital health startups, up nearly 75% from $21.7 billion in 2020.

Digital innovations are now being developed across the spectrum of healthcare, as the industry seeks to address critical gaps in care, remove geographic barriers, and create access to underserved patient populations.

To keep pace with these exciting innovations, the FDA and other regulatory agencies have expanded their focus. In September 2020, the FDA launched the Digital Health Center of Excellence and, over the past few years, has issued an array of new guidances for developers of Digital Medicines. Despite this focus on defining the regulatory pathways for Digital Medicines, these regulations are still in flux, and significant questions remain unanswered, with ‘grey’ areas where regulations may be only applied using ‘discretionary enforcement.’ This presents developers with both challenges and opportunities and a variety of development options that could lead to fundamentally different products being developed.

Click to read more in International Clinical Trials

International Clinical Trials, May 2022, pages 18-21. © Samedan Ltd